BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP E PROXIMAL SPIKE SET

    MDR report key: 6185913 · Received December 19, 2016

    Report

    Report Number
    1282497-2016-01063
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 30, 2016
    Report Date
    October 16, 2017
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. A SAMPLE WAS RECEIVED FOR EVALUATION. THERE WERE NO ISSUES FOUND WITH THE SAMPLE. THE REPORTED ISSUE COULD NOT BE CONFIRMED; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH AN ENTERAL FEEDING SET. THE CUSTOMER STATES FORMULA LEAKED FROM TUBING DURING USE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835676 JP E PROXIMAL SPIKE SET ENTERAL FEEDING SET LZH COVIDIEN 974655

    Patients

    Seq Age Sex Outcome Treatment
    1